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Tokyo Big Sight

11 nov 2018 9:30 a.m. - 13 nov 2018 5:40 p.m.

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

15th DIA Japan Annual Meeting 2018

Innovative technologies such as AI, big data/genomics, and cell/gene therapies are poised to transform healthcare product development across the globe – join us to discuss these topics.

[V8-S5] Improving Clinical Operation and Data Quality - eSource Is Transforming Clinical Trials -

Session Chair(s)

Takuhiro  Yamaguchi, PhD

Takuhiro Yamaguchi, PhD

Professor, Biostatistics

Tohoku University Graduate School of Medicine, Japan

ICT infrastructure is essential for the future clinical research and medical technology to provide scientific evidence. Project for Accelerating Medical Research through Cross-regional ICT Utilization is underway in Japan Agency for Medical Research and Development. The US FDA is driving the use of eSource. However, the adoption of eSource in clinical research has been delayed due to the difficulty of data manipulation. Data collection from eSource will be a more efficient way that will benefit patients, medical institutions and sponsors. In this session we will discuss challenges related to the use of eSource. We will also discuss how we can overcome them among industry, government and academia together.

Speaker(s)

Yasushi  Matsumura, MD, PhD

Direct Capture of Electronic Medical Record Data for Clinical Research

Yasushi Matsumura, MD, PhD

Osaka University, Japan

Professor, Division of Medicine, Graduate School of Medicine

Yoshihiro  Aoyagi, MS

Learning from EHR Data Utilization for Clinical Research / Clinical Trial

Yoshihiro Aoyagi, MS

National Cancer Center Hospital East, Japan

Manager, Department of Medical Information

Tempei  Miyaji, MSc

Challenges of Using Mobile in Clinical Research and Virtual Trial

Tempei Miyaji, MSc

The University of Tokyo, Japan

Project Assistant Professor, Department of Clinical Trial Data Management

Mika  Ogasawara

TransCelerate’s eSource Perspective

Mika Ogasawara

Pfizer R&D Japan G.K., Japan

Data Quality Lead, Biometrics and Data Management

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